There is a need in the medical field today for simple, expendable means to collect and convey debris generated during medical procedures from the office or room in which the procedure is performed for proper disposal of such debris. Such materials as must be contained and removed result from the use of cutting devices such as drills, cleaning picks, reamers, saws, and similar devices, and may comprise toenail dust, bone dust, clippings, and skin particles. Additionally, a need exists to minimize the exposure of medical personnel and subsequent patients to any contaminated airborne material that is produced during medical procedures on a patient. This requires a device that contains the bulk of the debris that is generated during a medical procedure, yet presents minimal interference to the medical practitioner's ability to perform the procedure. The device should additionally provide for the ready removal and disposal of the debris and be adapted for the ready cleaning of the device in preparation for the next patient. The device should perform these functions without the need to resort to the complexity of air exchange and filtration systems.
The best approach to the problem of containing residue of medical procedures is to provide containment of the contaminated material at its source, as opposed to removing it once it has passed into the procedure room environment or by requiring additional protective clothing to be worn by the medical personnel. A device affording this type of containment should permit the medical personnel to view the portion of the patient on whom the procedure is being performed while the device is in place. The device should permit the medical personnel to have their hands in close contact with the patient with minimum release of potentially contaminated material. Further, such a device should be inexpensive, disposable, and easy to use and clean.
In the past, numerous devices have been proposed that focus on the need to provide a barrier between the patient and the medical personnel. However very little thought has been given to the problem of containment and removal of the debris, which is as much a part of the sanitation problem as providing the barrier. Consequently, as will be seen in reviewing the prior art, the past devices do not include structure that is adapted for the ultimate containment and removal of debris generated during a medical procedure in addition to providing a barrier while the procedure is being performed.
U.S. Pat. No. 4,865,049 discloses a vacuum barrier specific for electrocautery surgery. It relies on a vacuum to capture the smoke generated during the procedure. It includes no device for capturing and disposing of heavier or larger particles. This device is mounted directly on the patient and thus requires an adhesive, which a significant number of people may be allergic to.
U.S. Pat. No. 4,936,318 discloses a transparent shield with means to draw a vacuum around the periphery of the shield. The shield is positioned over the recumbent patient. The device relies on the vacuum system to protect the environment outside of the shield from aerosol material that rises from the patient. Vacuums can fail to contain heavier particles, such as toenails. Vacuum units additionally have major limitations regarding portability, expense, cleaning and mechanical failure. The device offers no method of collecting debris that the vacuum fails to capture. The device is basically a single unit and would either need to be entirely covered with a disposable barrier itself or require extensive cleaning between procedures.
U.S. Pat. No. 4,998,538 discloses a medical drape specifically designed for laser surgery. As with the device discussed above, its usefulness also relies heavily on a vacuum unit and is burdened with the same limitations previously mentioned. The device relies on the walls of the drape wrapping onto the laser to be suspended therefrom. The materials used to make the barrier are strictly limited by laser safety precautions i.e., moisture-absorbent and nonflammable. The laser is directed perpendicular to the tissue to being operated on. The enclosed nature of the barrier would make procedures of even moderate length unacceptable without some sort of air transfer system. No provisions are included to remove any of the debris that is generated by the medical procedure after completion of the procedure.
U.S. Pat. No. 4,275,719 discloses an apparatus and method for providing aseptic surgical environment. This apparatus is a complex system requiring various accessory machines, i.e., air recirculation and sterilization equipment. The internal bag is designed to adhere a portion of the body and isolate the patient's body from the site of operation. The external structure is rigid and does not adjust to assist the practitioner's viewing of the site of operation. It offers no means of debris collection and disposal.
It would be a decided advantage to have a containment device that encloses the portion of the patient being operated on, that is supported in position ready for use, that is readily positioned about the portion of the patient that is to be operated upon, that provides for ready viewing of the site of the medical procedure, that provides for ready access of the medical practitioner's hands to the site of the medical procedure, that is naturally ventilated, and provides a means to conveniently collect and remove debris generated during the medical procedure.